Foundational Content Consolidation for Regulatory-Ready Digital End Points: Insights From Public-Private Partnerships

The rapid evolution of digital health technologies (DHTs) has created new opportunities and challenges for clinical research and regulatory science. The proliferation of DHTs highlights the need to effectively integrate DHT-derived measures into health care decision-making. As novel digital end points (NDEs) gain prominence in drug development, the need for robust, regulatory-ready measures is paramount. At the Digital Implementation Summit hosted by Pfizer and Johnson & Johnson in Cambridge, Massachusetts, in November 2025, leaders from Bayer, Pfizer, and DEEP Measures convened to discuss how content consolidation from public-private partnerships can accelerate the development and acceptance of regulatory-ready digital end points across multiple therapeutic areas. The panel, featuring Carrie Northcott (head, Digital Medicine and Translational Imaging, Pfizer), Jared Worful (global head of Digital Health Technology and Real World Science, Bayer), and Jacqueline Thong (general manager US, DEEP Measures), explored the challenges and opportunities in leveraging existing evidence, aligning terminology, and fostering collaboration across the industry.

Setting the stage: The need for content consolidation

The Foundational Content Consolidation initiative aimed to consolidate evidence from public-private partnerships, academia, and other public sources to develop regulatory-ready NDEs. The project used the Innovative Health Initiative’s (IHI) in-kind contributions to additional activities incentive to systematically consolidate, evaluate, and structure NDEs. By evaluating NDEs in key therapeutic areas, identifying evidence gaps, and outlining regulatory strategies, the project sought to streamline the path from innovation to clinical application. At the Digital Implementation Summit, the panel framed the topic of NDE acceleration as a process of “reduce, reuse, and recycle”: streamlining efforts, reusing evidence when possible, and recycling available evidence for broader applications. The European Federation of Pharmaceutical Industries and Associations encouraged organizations like DEEP Measures to leverage evidence from legacy Innovative Medicines Initiative (IMI) and IHI projects to drive utilization of their work across domains and therapeutic areas. The overarching goal was to identify evidence gaps and formulate regulatory strategies with industry partners to advance NDEs.

Methods: Mining and structuring evidence

The initiative used a structured content model to organize and assess NDEs. This included:

• Systematic identification and aggregation of relevant literature and data from legacy IMI/IHI projects (eg, Mobilise-D,¹ IDEA-FAST,² PROactive,³ RADAR-AD⁴) and authoritative public sources such as C-Path and DiMe.
• Consolidation of digital measure definitions, meaningful aspects of health, and concepts of interest (COI) into a structured catalog across domains, including physical activity, sleep, cognition, and speech.
• Assessment and unification of naming conventions, terminology, and ontology.
• Regulatory-readiness assessments, covering validation, gap analysis, and risk mitigation.

A web-based platform served as a neutral repository that enabled teams to catalog, search, and reuse evidence. Systematically structuring evidence measurement definitions, technological requirements, and potential solutions helped to simplify and unify terminology, reduce duplicated validation work, highlight potential synergies, and identify evidence gaps.

Results

The Foundational Content Consolidation initiative evaluated NDEs in physical activity, sleep, speech, and cognition across multiple therapeutic areas. Key outcomes from this effort included:

• Creation of 5 measurement definitions and 6 target solution profiles—standards and technical requirements for DHT solutions.
• NDEs were mapped for 3 indications, with COI in physical activity (activities of daily living, exercise tolerance), in sleep (respiratory difficulties, sleep impairment), and in speech/cognition (executive function, memory).
• Solution requirements were compared against current standards and evaluated for risks and advancement potential based on existing evidence.
• Identification of subsequent evidence generation requirements and regulatory strategy.

Together, these outcomes offer a road map for using NDEs in future clinical trials. Consistent engagement with stakeholders supported iteration and alignment of the work. Learnings from industry partners at differing stages of their NDE journey were shared during the Digital Implementation Summit.

Discussion

Organizational knowledge and collaboration

The panel emphasized the need to consolidate organizational knowledge to prevent the loss of knowledge and reduce duplicated efforts due to organizational or personnel changes. Centralized platforms enable teams to capture, share, and reuse information, limiting duplication of efforts and fostering efficient implementation of DHTs.

Neutral platforms can bridge silos and encourage early collaboration between clinicians and digital health teams, both within organizations and across the industry. These tools help drive alignment, de-risk investments, and accelerate the validation and acceptance of NDEs.

Terminology, ontology, and alignment

A recurring challenge is aligning terminology and ontology across organizations (eg, academic, industry, manufacturers) and regulatory bodies. For example, physical activity is a complex construct, encompassing various subdomains and definitions. Harmonization, such as distinguishing between physical activity, physical function, and related terms, even at a high level, is essential for several reasons. First, a common understanding of measures and their clinical value ensures alignment and helps avoid delays in advancing NDEs. Ultimately, once organizations are aligned on the terminology and definitions surrounding an NDE, they are better positioned for effective and clear evidence development, consolidation, and communication.

At a detailed level, the physical activity concepts such as gait speed, nonsedentary activity, sedentary activity, moderate to vigorous physical activity, etc, also require consistent definitions. Alignment must start with high-level concepts and extend through detailed measurement terminology. NDEs allow more precise measurement of health impacts, but this also demands a rigorous definition of what is being measured.

Structured approaches to regulatory strategy

Structured tools and platforms provide a road map for addressing contexts of use, concepts of interest, validation, verification, and other critical components, ensuring necessary steps and evidence are in place prior to regulatory interactions. The granularity of such tools supports more effective planning for regulatory interactions and investment decisions. Platforms that capture and share learnings improve transparency, simplify review processes, and drive industry alignment, ultimately making patient data easier to interpret and use across DHTs.

Community and industry impact

The Foundational Content Consolidation initiative underscores the value of community-driven collaboration. Although drug development typically occurs within individual companies, NDE development affords opportunities for cross-industry collaboration to establish shared foundational building blocks that enhance development and, in turn, benefit patients. Sharing learnings through neutral platforms can drive industry-wide progress. Panelists advocated for continued openness and persistence, noting that regulatory-ready digital end points require sustained, collective effort.

Best practices

Panelists offered practical guidance for teams implementing digital end points:

• Engage health care providers and patients early to identify measures that translate into relevant and meaningful NDEs.
• Capture organizational learnings and use platform tools to help facilitate internal and external collaboration.
• Start with clear, patient-relevant questions and hypotheses, and avoid chasing the latest technologies without evaluating whether they have sufficient evidence or meet the appropriate technological requirements.
• Embrace persistence and adaptability by taking a step-by-step approach, pivoting when needed, and learning from mistakes to manage the complexity and drive progress.

Conclusion

The Foundational Content Consolidation initiative, showcased at the Digital Implementation Summit, demonstrates a scalable and collaborative approach to advancing regulatory-ready NDEs. By consolidating evidence, harmonizing terminology, developing a clear ontology, and fostering early collaboration, the project lays the foundation for regulatory acceptance and real-world adoption of NDEs in clinical trials and potentially beyond.

As digital medicine continues to evolve, openness, focus, and community will be key to realizing the full potential of digital measures of health. The learnings from this work offer a road map for organizations navigating the complexities of digital end point development and regulatory science.

Arvind Ramanujam, MS, science liaison team lead, DEEP Measures; Carrie Northcott, PhD, head, Digital Medicine and Translational Imaging, Pfizer; Jacqueline Thong, MBA, general manager US, DEEP Measures; and Jared Worful, MS, MBA, global head of Digital Health Technology and Real World Science, Bayer

Footnotes

1. Mobilise-D: Connecting digital mobility assessment to clinical outcomes for regulatory and clinical endorsement; produced, validated and accepted digital mobility outcomes to monitor the daily life gait of people with various mobility problems, aiming to improve follow-up and personalized care

2. IDEA-FAST: Identifying Digital Endpoints to Assess Fatigue, Sleep and Activities of Daily Living in Neurodegenerative Disorders and Immune-mediated Inflammatory Diseases

3. PROactive: Physical Activity as a Crucial Patient Reported Outcome in COPD—the PROactive project developed innovative patient reported outcome (PRO) tools to measure patients’ experience of physical activity in terms of “amount” of activity and “difficulty”

4. RADAR-AD: Remote assessment of disease and relapse – Alzheimer’s disease; developed a digital platform that would draw on smartphone, wearable and home-based digital technologies to track subtle changes in the cognitive and functional abilities of people with Alzheimer’s disease